www.HIMSSConference.org
#PrecisionHIT
FEBRUARY 11, 2019
ORLANDO, FL
Four Legal Issues for Providers
of Precision Medicine
Agenda:
Privacy the balance between conducting research and
protecting genetic information.
Regulatory innovation versus regulation?
Discrimination GINA and its gaps.
Fraud & Abuse is free or reduced-cost testing allowed?
Why should we care about privacy?
Your genome is more personal than a fingerprint
It’s unique to you
It says a lot about you & your health
Privacy concerns about genetics
What research is being done and where?
Publicly available sequence banks
Uses by law enforcement
What is appropriate informed consent and when should you get
it?
Privacy Issues
What is appropriate use of genetic information?
Current legal framework:
HIPAA
Allows use of data for research
Allows sharing of “de-identified” data
OHRP
Only applies to Human Subjects Research
Systematic investigation designed to develop or contribute to generalizable
knowledge
Privacy Issues
Common Rule
Proposed Rule modified Human Subjects Research to include
biospecimens
Did not include use of data
80% of respondents addressing this provision opposed it
Final rule continues to allow the use of de-identified biospecimens for
secondary research
Privacy Issues
The Final Rule requires:
Re-examine the definition of the terms "identifiable
private information" and "identifiable biospecimen."
Assess whether there are "analytic technologies
…generate identifiable private information or
identifiable biospecimens."
Recommendations on consent, privacy, and data
protections that will go through a public comment
process.
Consent requirements must be balanced with research
needs
Privacy Issues
State law restrictions
What is research?
What is allowed without express consent?
Informed Consent Requirements
How much information should be given about tests and the
research?
About third party collaborations?
Right to have access to results?
When should consent be done?
Clinical setting prior to research?
At the time the research protocol is developed?
Issues in Clinical Care
Variants of Uncertain Significance
Duty to report?
Give patient false security
Give patient unwarranted fear
Reinterpretation?
Recontact
To whom to report
Billing
Williams. Athena case update
Direct-to-Consumer Testing
Should patients have access to their genome?
Can they understand the results?
Do they understand consent for research / third party
collaborations?
Open platform services:
Data available to all
Use by police
FDA Regulating LDTs
Today, lab test quality governed by CLIA regulations
NY statutes
FDA would like to require labs get clearance before offering
test
Some genetics testing considered highest risk
FDA Laboratory Developed Tests
Draft Guidance October 2014
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguid
ance/guidancedocuments/ucm416685.pdf
White Paper January 2017
https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalPro
cedures/InVitroDiagnostics/LaboratoryDevelopedTests/UCM536965.pdf
Draft Diagnostic Accuracy and Innovation Act March 2017
https://bucshon.house.gov/sites/bucshon.house.gov/files/documents/dai
a%20discussion%20draft.pdf
©MFMER | 18
FDA Laboratory Developed Tests
FDA issued Technical Assistance response August 2018
http://www.fdalawblog.net/wp-content/uploads/2018/08/FDA-LDT-Draft-
Leg.pdf
Gottlieb Comments at Forum September 2018
https://www.fda.gov/NewsEvents/Speeches/ucm620375.htm
©MFMER | 19
VALID Act
Verifying Accurate, Leading-edge IVCT Development
(“VALID”) Act
https://degette.house.gov/sites/degette.house.gov/files/vali
d_act_discussion_draft_12.6.18.pdf
Incorporates more feedback from FDA on their recent
Technical Assistance document
http://www.fdalawblog.net/wp-
content/uploads/2018/08/FDA-LDT-Draft-Leg.pdf
FDA Regulating LDTs
Should genetic testing be subject to higher standards for
accuracy?
FDA has identified many of these as high risk
Should clinical studies be performed to determine whether
the tests add value to health of patient?
Adds to cost of healthcare
Where does testing end and practice of medicine begin?
Direct-to-Consumer Testing
Should patients have access to their genome?
Can they understand the results?
Will it cause panic because some variants are of uncertain
significance?
Office of Civil Rights stated NGS test results should be
part of the “designated record set” under HIPAA.
Burdensome to lab
Worrisome to patient?
Discrimination
Genetic Information Nondiscrimination Act
Became law in 2008
Goal is to protect individuals from discrimination
based on genetic information
Health Insurance
Employment discrimination
Does not cover life insurance, disability insurance, or
long-term care insurance
Discrimination
Patients worried about results for these purposes
What if a patient requests to have these results
removed from their medical record?
Out-of-Pocket Max Programs
What’s the issue?
Testing may be expensive to patient
Lack of CPT Availability
Lack of coverage by health plans
Preauthorization may be required
Providers want to use labs with limited charges to patients
Labs try to meet that objective by waiving co-pays, or
guaranteeing a cap on the amount paid out of pocket
Out-of-Pocket Max Programs
What’s the Problem?
Can be breach of the patient’s health plan
Tortious interference with contract
Can violate state laws against deceptive and unfair trade practices
Fraudulent practices
Inducement
Unlawful kickbacks
Unjust enrichment claims
Out-of-Pocket Max Programs
Several lawsuits calling out practices of:
“Fee forgiveness” program to members, but members never
received a bill
Copayments and deductibles routinely waived without regard to
patient’s ability to pay
Cap on out of pocket no matter what insurance covers
OIG Advisory Opinion 15-4
Agreements not to bill for out-of-network fees was rejected as
potential kickback
Out-of-Pocket Max Programs
United Health v. Sky Technologies
Claimed $50 million in damages
Cigna v. HDL
Claimed $84 million in damages
DOJ settled with HDL for $48.5 million
False claims
Unlawful inducements
Out-of-Pocket Max Programs
United Healthcare memo to labs:
United Healthcare warns labs against waiving patient fees,
copayments, and deductibles
“UnitedHealthcares benefit contracts exclude coverage for any
out-of-network lab services for which the provider waives the
coinsurance, copayments, or deductibles
In addition, routine waiver of coinsurance, copayments, or
deductibles may be a violation of the federal False Claims Act,
subject to investigation by the Office of the Inspector General and/or
any applicable state insurance department’s fraud division,” wrote
UHC
Out-of-Pocket Max Programs
OIG Special Fraud Alert
https://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html
(December 1994)
“Routine waiver of deductibles and copayments by charge-
based providers, practitioners or suppliers is unlawful
because it results in (1) false claims, (2) violations of the anti-
kickback statute, and (3) excessive utilization of items and
services paid for by Medicare.”
www.HIMSSConference.org
#PrecisionHIT
Sharon C. Zehe, JD
Mayo Clinic